Pfizer says its Covid vaccine is STILL 100% effective in children ages 12 to 15 four months after the second dose
- Pfizer-BioNTech released data on Monday from a long-term analysis of their COVID-19 vaccine in kids aged 12 to 15
- There were 30 confirmed symptomatic Covid cases in the placebo group compared to none in the vaccinated group
- Researchers say this equates to 100% efficacy at least four months after receiving the second dose
- The vaccine is currently only fully approved for those aged 16 and older but the companies plan to apply for extended approval in the 12-15 age group soon
Pfizer-BioNTech said on Monday that their COVID-19 vaccine provides long-lasting protection among adolescents.
The companies released data showing the shot was 100 percent effective against infection among 12-to-15-year-olds four months after the second dose.
The follow-up to the initial phase III clinical trial data showed no serious adverse events or safety concerns.
The vaccine was granted emergency use authorization for younger teens in May and the companies hope the data will soon be submitted to the U.S. Food and Drug Administration (FDA) to receive full approval.
Pfizer-BioNTech released data on Monday from a long-term analysis of their COVID-19 vaccine in kids aged 12 to 15. Pictured: Nurse Erin Morgan administers the Pfizer COVID-19 vaccine to 14-year-old Zach Bilyj, of Wake Forest, North Carolina, May 2021
There were 30 confirmed symptomatic Covid cases in the placebo group compared to none in the vaccinated group, equating 100% efficacy. Pictured: Vials containing doses of Pfizer’s COVID-19 vaccine, undated
‘These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a Covid- 19 vaccine in individuals 12 to 15 years of age,’ Ugur Sahin, CEO and co-founder of BioNTech, said in a statement.
‘The growing body of data we have compiled from clinical trials and real-world surveillance to date strengthen the base of evidence supporting the strong efficacy and favorable safety profile of our Covid-19 vaccine across adolescent and adult populations.’
In the trial, 2,228 teenagers were enrolled in the U.S. compared to 40,000 for the aged 16 and older trial.
Half of the group received two doses of the vaccine three weeks apart and the other half were given two placebo injections.
The 30 microgram dose is the same dose that is given to older teens and adults.
Among the participants, there were 30 confirmed symptomatic Covid cases without evidence of prior infection, all in the placebo group.
This corresponds to a vaccine efficacy of 100 percent. Efficacy was consistently high across gender, race, obesity levels and comorbidity status.
The main safety concern among this age group is vaccine-linked myocarditis, a rare type of heart inflammation, in young males under age 30.
But such cases are very rare, and the benefits of vaccination continue to strongly outweigh the risks, data has shown.
Covid itself can cause myocarditis, both more often and a more severe form.
‘As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine’s safety and effectiveness profile in adolescents,’ said Pfizer CEO Albert Bourla in a statement.
‘This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed. We look forward to sharing these data with the FDA and other regulators.’
It is unclear when Pfizer plans to apply for full approval with the FDA, but officials have hinted they may do so before the end of the year.
The vaccine is currently only fully approved in Americans aged 16 and older.
Source: Read Full Article